Trial record 16 of 16 for:    "Advance Directives" | Open Studies

Preparing Spanish-speaking Older Adults for Advance Care Planning and Medical Decision Making (PREPARE)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2014 by University of California, San Francisco
Sponsor:
Collaborator:
Patient Centered Outcome Research Institute
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT02072941
First received: February 24, 2014
Last updated: February 26, 2014
Last verified: February 2014
  Purpose

In partnership with patients, caregivers, advocacy groups and clinicians, the investigators plan to:

Aim 1: Adapt and refine PREPARE in Spanish through cognitive interviews with Spanish-speaking Latinos and stakeholders.

Aim 2: Conduct an RCT to compare the efficacy of PREPARE plus a previously-tested, easy-to-read- AD (intervention) versus the AD alone (control) to:

2a. Engage older Spanish-speaking Latinos in multiple ACP behaviors (i.e., identify and discuss wishes with surrogates and clinicians and complete ADs) measured by self-report, chart review, surrogate reports, and

2b. Direct observation.

2c. Improve self-efficacy and satisfaction with medical decision making.

2d. Determine whether PREPARE efficacy varies by literacy, decision control preferences, and clinician-patient language concordance.

Aim 3: Disseminate PREPARE with input from patients, surrogates, and stakeholders.


Condition Intervention
Chronic Disease
Behavioral: PREPARE Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: Preparing Spanish-speaking Older Adults for Advance Care Planning and Medical Decision Making

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Change in engagement in advance care planning behavior using validated surveys at 12 months from baseline [ Time Frame: 12 months from baseline ] [ Designated as safety issue: No ]

    Engagement in 5 behaviors that is a composite outcome of ACP engagement.

    1. Advance Directive completion - An advance directive form, a living will, a durable power of attorney for health care, Physicians Orders of Life Sustaining Treatment, or other documentation, such as code status.
    2. Advance care planning discussions with surrogates - Asking someone to be a surrogate, talking about goals for medical care, whether to grant leeway, or discussions relating to medical decision making or prognosis.
    3. Advance care planning discussions with clinicians - Discussions concerning a surrogate, goals for medical care, whether to grant surrogates leeway, or discussions relating to medical decision making or prognosis.
    4. Inform others (friends/family member identified as important) - Discussions about advance care planning-related topics
    5. Ask doctors questions - risks, benefits, options.

    These behaviors will be measured using validated surveys on a 1 to 5 scale.



Secondary Outcome Measures:
  • Change in advance care planning behavior at 12 months from baseline [ Time Frame: 12 months from baseline ] [ Designated as safety issue: No ]
    1. Advance care planning behavior change
    2. Self-efficacy with advance care planning behaviors
    3. Engagement in medical decision making
    4. Satisfaction with medical decision making
    5. Surrogate-reports of patient engagement in advance care planning


Estimated Enrollment: 402
Study Start Date: April 2014
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PREPARE intervention
The PREPARE arm will review the PREPARE website plus the easy-to-read advance directive (AD). Participants will review PREPARE on their own for ≥20 minutes with staff present to answer questions. During PREPARE, participants answer preference questions and make an action plan (i.e., commitment to engage in advance care planning). To ensure home access to PREPARE content, participants will be given a website login and PREPARE content in digital video disc (DVD), booklet, and pamphlet format as well as the action plan and AD. One to three days before a primary care visit, the PREPARE arm will receive a reminder to come to their appointment and to bring their action plan.
Behavioral: PREPARE Intervention
At week 1, 3, 6, and 12 months, interviews (telephone or in person based on preference) by blinded staff will assess engagement in advance care planning (ACP), self-efficacy with ACP, and activation in and satisfaction with decision making. Blinded telephone interviews will also assess surrogate reports of patient engagement in ACP.
No Intervention: Control
The control arm will review an easy-to-read AD. Controls will review the AD for ≥15 minutes with study staff present to answer questions and will take the AD home to complete if desired. One to three days before a primary care visit, controls will receive a reminder to come to their appointment.

Detailed Description:

PREPARE is a website (www.prepareforyourcare.org) that teaches patients how to identify what is most important in life, how to communicate their preferences to clinicians and loved ones, and how to make informed decisions. It is written at a 5th grade level and includes voice-overs of text and closed captioning of videos that model advance care planning behaviors. The goal of this proposal is to test the efficacy of PREPARE plus an easy-to-read advance directive, versus an advance directive alone, to improve patient engagement in multiple advance care planning behaviors including discussions with surrogate decision makers and clinicians in addition to advance directive completion. The investigators will also determine whether PREPARE can empower and activate patients within clinical encounters with their clinicians and help to decrease health disparities in advance care planning.

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Spanish-speaking adults ≥ 55 years of age
  • ≥ 2 chronic illnesses determined by ICD-9 codes
  • ≥ 2 visits with an outpatient primary care clinician at San Francisco General hospital in the past year
  • ≥ 2 additional outpatient/inpatient visits to San Francisco General Hospital in the past year

Exclusion Criteria:

  • Deaf, blind, demented or psychotic as determined by ICD-9 codes
  • Too mentally or physically ill to participate as determined by their clinicians
  • Moderate or severe cognitive impairment as determined by the Short Portable Mental Status Questionnaire (SPMSQ), and mild cognitive impairment by the SPMSQ plus an abnormal Mini-Cog (scores minimally affected by education/ethnicity)
  • Self-reported poor vision and inability to see the words on a newspaper
  • Lack of a telephone (for follow-up)
  • Traveling or moving out of the area for ≥3 months during the study follow-up period.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02072941

Contacts
Contact: Rebecca Sudore, MD 415-221-4810 ext 3475 rebecca.sudore@ucsf.edu
Contact: Jenelle Lin, MSPH jenelle.lin@ucsf.edu

Locations
United States, California
San Francisco General Hospital and Trauma Center Not yet recruiting
San Francisco, California, United States, 94110
Contact: Rebecca Sudore, MD    415-221-4810 ext 3475    rebecca.sudore@ucsf.edu   
Contact: Jenelle Lin, MSPH       jenelle.lin@ucsf.edu   
Principal Investigator: Rebecca Sudore, MD         
Sponsors and Collaborators
University of California, San Francisco
Patient Centered Outcome Research Institute
Investigators
Principal Investigator: Rebecca Sudore, MD University of California, San Francisco
Principal Investigator: Dean Schillinger, MD University of California, San Francisco
Principal Investigator: Deborah E Barnes, PhD University of California, San Francisco
Principal Investigator: John Boscardin, PhD University of California, San Francisco
Principal Investigator: Janet Shim, PhD University of California, San Francisco
  More Information

Additional Information:
No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02072941     History of Changes
Other Study ID Numbers: P0061026, R-1306-01500
Study First Received: February 24, 2014
Last Updated: February 26, 2014
Health Authority: United States: Data and Safety Monitoring Board
United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
Advance care planning
Latino Health
Medical decision making
Health Literacy
Limited English proficiency
Aging

Additional relevant MeSH terms:
Chronic Disease
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on July 29, 2014